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Testing Training Programs to Improve Children's Pedestrian Behaviors

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ClinicalTrials.gov Identifier: NCT03960047
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Barbara A. Morrongiello, PhD, C. Psych., University of Guelph

Brief Summary:

Motor vehicle pedestrian injury is a critical issue for school children.1-4 Each year in the US, over 4900 pedestrians are killed and another 207,000 are injured, and about 25% of these pedestrian events involve school-age children. This research focuses on 7-8 year olds, who constitute a high-risk group for pedestrian injury. At these ages children regularly cross streets without supervision and they struggle both with selecting where to cross and determining how to cross. Research has shown, however, that children are capable of benefiting from effective behavioral training in pedestrian behavior. The proposed research addresses the issue of crossing skills deficits and will: (1) implement a randomized controlled trial (RCT) to test two alternative training programs to teach 7-8 year-olds where and how to cross streets safely; and (2) conduct an economic analysis to reveal cost:benefit indices for both.

Meta-analyses of pedestrian training programs reveal that behavioral training in a traffic environment most reliably produces some degree of improvement in crossing skills. Thus, 'street-side training' is often described as the gold standard. Implementation, however, poses many practical problems related to implementation. The investigators have addressed this issue by developing a training system that uses a virtual pedestrian environment and extends past VR systems by having children fully cross the street and offering the unique capability of teaching both where and how to cross, with skills in each domain measured separately so exactly what is learned and what component crossing behaviors improved can be precisely determined for each individual child.

Children (7-8 years) will be randomized to one of three groups (balanced for sex): street-side training, virtual-reality training, and a no-intervention control, with the same pre- and post- measures taken across groups. Primary analyses will test for changes in indices of where and how to cross, as well as attention to traffic when crossing. An economic analysis of the two programs will reveal their relative cost effectiveness. These results will provide essential knowledge to inform future decisions about 'best practices' in child pedestrian injury prevention through behavioral training.


Condition or disease Intervention/treatment Phase
Child Behavior Behavioral: Virtual Reality Training Behavioral: Streetside Training Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Control Intervention: Virtual Reality training Intervention: Streetside training
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Testing a Training Program That Uses Virtual Reality Technology to Improve Children's Pedestrian Behaviors: A Randomized Controlled Trial
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : June 1, 2021

Arm Intervention/treatment
Experimental: Intervention: Virtual Reality Training
Uses virtual reality to train children to cross streets
Behavioral: Virtual Reality Training
This group gets trained to cross streets using virtual reality

Experimental: Intervention: Streetside Training
Train children to cross streets using real traffic in curbside locations
Behavioral: Streetside Training
This group is trained to cross streets based on streetside experiences

No Intervention: Control
Receives no intervention



Primary Outcome Measures :
  1. Index of crossing safely: Hit by car [ Time Frame: 6 weeks ]
    Proportion of trials on which child would be hit by a car when crossing (based on average walking speed)

  2. Index of child looking to traffic [ Time Frame: 6 weeks ]
    Proportion of trials the child looked left-right-left before crossing

  3. Index of crossing safely: Where to cross [ Time Frame: 6 weeks ]
    Proportion of trials the child chose the safe place to cross (hill, blind curve, parked cars)

  4. Index of crossing safely: When to cross [ Time Frame: 6 weeks ]
    Average inter-vehicle gap selected across all trials (in seconds)

  5. Economic analysis - Estimated Costs of Programs [ Time Frame: 24 months ]
    Overall average cost to implement each of the 2 training programs



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Ages Eligible for Study:   7 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • English speaking

Exclusion Criteria:

  • History of pedestrian injury

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03960047


Contacts
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Contact: Barbara Morrongiello, PhD 519-824-4120 ext 53086 bmorrong@uoguelph.ca

Locations
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Canada, Ontario
University of Guelph Recruiting
Guelph, Ontario, Canada, N1G2W1
Contact: Sandy Auld, MA    519-824-4120    sauld@uoguelph.ca   
Contact: Stephen Lewis, PhD    519-824-4120    slewis03@uoguelph.ca   
Principal Investigator: Barbara A Morrongeillo, PhD         
Sponsors and Collaborators
University of Guelph
Investigators
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Principal Investigator: Barbara Morrongiello, PhD University of Guelph

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Responsible Party: Barbara A. Morrongiello, PhD, C. Psych., Professor in Psychology, University of Guelph
ClinicalTrials.gov Identifier: NCT03960047     History of Changes
Other Study ID Numbers: 1R21HD093878-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Barbara A. Morrongiello, PhD, C. Psych., University of Guelph:
children
crossing streets
training